← Product Code [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE) · K970040 # SPINE-TECH BONE HARVESTER (K970040) _Spine-Tech, Inc. · HWE · Feb 28, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K970040 ## Device Facts - **Applicant:** Spine-Tech, Inc. - **Product Code:** [HWE](/submissions/SU/subpart-e%E2%80%94surgical-devices/HWE.md) - **Decision Date:** Feb 28, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4820 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur. This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal. All components of the Spine-Tech Bone Harvested are intended for single use only. ## Device Story Manual/powered surgical instrument for harvesting morselized autogenous bone graft; consists of cutting head, collection tube, trocar, and plunger. Operates by cutting bone tissue; collected graft stored in tube; removed via trocar and plunger. Used in OR by surgeons. Benefits patient by providing autogenous graft for fusion/defect filling. Single-use device. ## Clinical Evidence Bench testing only; includes biocompatibility testing per ASTM standards, dimensional inspection, and workmanship inspection. All results acceptable. ## Technological Characteristics Materials: stainless steel (cutting heads, trocar), medical grade polycarbonate (collection tube, adapter), acetal copolymer (plunger). Manual or power-driven (Hudson/Hall fitting). Single-use. ## Regulatory Identification Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade. ## Predicate Devices - Acumed Bone Graft System - Spine-Tech Bone Harvester, Non-Powered - General and Orthopedic Surgical Instruments, Accessories/Attachments ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K970040 FEB 28 1997 # 510(k) Summary ## Spine-Tech Bone Harvester ### General Information | Classification | Class I | | --- | --- | | Trade Name | Spine-Tech Bone Harvester | | Submitter | Spine-Tech, Inc. 7375 Bush Lake Road Minneapolis, MN 55439-2029 (612) 832-5600 | | Contact | David A. Cannistraci Director of Regulatory Affairs (612) 832-5600 | ### Predicate Devices - Acumed Bone Graft System - Spine-Tech Bone Harvester, Non-Powered - General and Orthopedic Surgical Instruments, Accessories/Attachments ### Intended Use The Spine-Tech Bone Harvester is indicated for the cutting and collection of morselized autogenous bone graft from the anterior or posterior iliac crest, tibia or femur. This device is intended to cut and collect finely morselized autogenous bone graft for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include; spinal fusion, joint arthrodesis, total joint replacement, fracture repair, maxillofacial reconstruction and tumor removal. All components of the Spine-Tech Bone Harvested are intended for single use only. {1} ## Device Description The Spine-Tech Bone Harvester consists of two cutting head/collection tube sizes, Hudson or Hall fitting adapter for power use, trocar and plunger. The cutting heads and trocar are constructed from stainless steel. The collection tube and adapter are constructed from medical grade polycarbonate. The plunger is constructed from acetal copolymer. After cutting and collection of morselized bone graft, the cutting head is removed from the collection tube with the trocar and bone is pushed out of the collection tube with the plunger. ## Testing Biocompatibility testing has been performed on the materials used in the construction of this device and is documented in the ASTM Standard. Performance and quality testing of the product included bench testing, dimensional and workmanship inspection. All testing of the device yielded acceptable results. ## Summary of Substantial Equivalence The Spine-Tech Bone Harvester is substantially equivalent in material, design, and function to Acumed Bone Graft System and other general and orthopedic surgical instruments used for the harvesting of autogenous bone. Due to the similarity of materials and design to both pre-enactment and post-enactment devices, Spine-Tech believes that the Spine-Tech Bone Harvester does not raise any new safety or effectiveness issues. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K970040](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWE/K970040) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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